Surgical constructs and methods of tissue repair

ABSTRACT

Systems and methods for soft tissue to bone repairs employing tensionable knotless anchors, without knot tying. The tensionable knotless anchors may be used by themselves or in combination with additional constructs (which may have a similar or different configuration, i.e., modified according to the specific repair) to achieve novel remplissage and soft tissue repairs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 16/419,801, filed May 22,2019, now U.S. Pat. No. 11,439,382, which is a continuation ofapplication Ser. No. 14/918,401, filed Oct. 20, 2015, now U.S. Pat. No.10,368,855, the disclosures of which are incorporated by reference intheir entireties herein.

BACKGROUND

The present invention relates to methods of tissue repair and surgicaldevices and, in particular, to suture constructs and associated methodsof remplissage and tissue repairs.

SUMMARY

Knotted or knotless, tensionable fixation devices and methods of tissuerepairs and remplissage techniques are disclosed.

Suture anchors provide significant stabilizing effect of bringing softtissue into a bone defect and fixing soft tissue within the bone defect.Suture anchors allow for tensioning after insertion in bone defect (toallow attached tissue to be brought proximate to bone) and do notrequire tying of any knots.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a, 1 b , and 2 illustrate various views of a fixation deviceaccording to an exemplary embodiment.

FIGS. 3 and 4 illustrate various views of a fixation device according toanother exemplary embodiment.

FIGS. 5 and 6 illustrate various views of a fixation device according toanother exemplary embodiment.

FIGS. 7 and 8 illustrate various views of a fixation device according toanother exemplary embodiment.

FIGS. 9 and 10 illustrate various views of a fixation device accordingto another exemplary embodiment.

FIGS. 11-15 illustrate an exemplary remplissage technique with fixationdevices of FIGS. 1-10 .

FIGS. 16-18 illustrate another exemplary remplissage technique withfixation devices of FIGS. 1-10 .

FIGS. 19-21 illustrate another exemplary remplissage technique withfixation devices of FIGS. 1-10 .

FIGS. 22-25 illustrate another exemplary remplissage technique withfixation devices of FIGS. 1-8 .

FIGS. 26 and 27 illustrate a side view and a cross-sectional view,respectively, of a tensionable knotless suture construct employed inexemplary methods of tissue repairs and remplissage techniques.

DETAILED DESCRIPTION

Surgical constructs, devices, systems, remplissage techniques, and softtissue repairs such as transtendon repairs (for example, PartialArticular Surface Tendon Avulsion (PASTA) lesion repairs) or otherknotless soft tissue repairs and fixations, such as fixation of softtissue (ligament, tendon, graft, etc.) to bone, are disclosed. Theknotless anchor constructs may be employed for any remplissagetechniques such as Hill Sach's repairs and for any soft tissue repairsincluding PASTA, labral, rotator cuff, Achilles tendon, biceps and hiprepairs, among many others.

The knotless suture constructs disclosed below use a mechanism similarto that of knotless SutureTak® but provide improvements in the design ofthe anchor constructs. As detailed below, novel anchor constructs in theform of (1) a combined knotless/knotted Corkscrew® anchor with arecessed eyelet; (2) a knotless Corkscrew® anchor; (3) a knotlessSwiveLock® anchor with a recessed eyelet; and/or (4) a knotlessPushLock® anchor may be used alone or in any combination to aid insuture management and tensioning.

Knotless suture anchors are provided for both PASTA and remplissageapplications. These anchors have specific application to the humeralbone and have increased pullout strength.

The surgical devices (constructs) detailed below include fixationdevices (tensionable knotless anchors) having various configurationsthat are inserted into a bone defect (such as a Hill Sach's lesion, forexample) with a flexible strand (for example, a suture) provided withinthe fixation device and optionally a shuttle/pull device (a suturepassing instrument) attached to the flexible strand. The flexible strandand the shuttle/pull device attached to it allow the formation of asplice within the body of the anchor, or outside the body of the anchor,and during the tissue repair procedure to finalize the construct. Theshuttle/pull device is provided within the strand (inside of the strand)and forms the splice subsequent to the insertion of the fixation devicewithin the bone (and subsequent to attachment to soft tissue to berepaired or fixated) to allow formation of the final fixation devicewith a knotless self-locking mechanism including a continuous, flexibleloop having an adjustable perimeter that allows the user (for example,the surgeon) to control the tension of the strand on the soft tissue tobe attached to bone.

Details of the formation of an exemplary knotless suture anchor employedin the embodiments of the present invention and with the splice- andloop-forming mechanism detailed above are set forth in U.S. Pat. No.9,107,653, entitled “Tensionable Knotless Anchors with Splice andMethods of Tissue Repair,” U.S. Patent Application Publication No.2013/0165972, entitled “Tensionable Knotless Anchor Systems and Methodsof Tissue Repair,” and U.S. Patent Application Publication No.2013/0345749, entitled “Knotless Suture Anchors and Methods of TissueRepairs,” the disclosures of all of which are incorporated by referencein their entirety herewith.

The present invention also provides remplissage techniques and methodsof soft tissue repairs which do not require tying of knots and allowadjustment of both the tension of the suture and the location of thetissue with respect to the bone defect or lesion. In the exemplarymethods detailed below with reference to FIGS. 1-25 , the tensionableknotless anchors may be used by themselves or in combination withadditional constructs (which may have a similar or differentconfiguration, i.e., modified according to the specific repair) and withthe flexible strand provided through tissue, around tissue, or throughand around tissue to be fixated within the bone defect. The tensionableknotless anchors may be used to achieve simple stitch repairs, mattressstitch repairs or interlocked looped mattress repairs, among others, atthe bone defect, preferably within the bone defect. The tensionableknotless anchors may be also provided in a daisy chain configuration,i.e., with the suture from one anchor passed through the eyelet/loop ofthe shuttle/pull device of another anchor and repeated in a pattern (toallow the formation of a splice within each anchor with a shuttle/pulldevice of another anchor).

The methods and devices (constructs) of the present invention will bedetailed below with reference to exemplary knotless, self-cinchingsuture anchors 50 a, 50 b, 50 c, 50 d, 50 e, 50 f, 50 g. Details of ananchor similar in part to knotless suture anchors 50 a, 50 b, 50 c, 50d, 50 e, 50 f, 50 g are set forth in U.S. Pat. No. 9,107,653 issued Aug.18, 2015, entitled “Tensionable Knotless Anchors with Splice and Methodsof Tissue Repair (the disclosure of which is incorporated in itsentirety herewith), and are also provided in this application (for easeof understanding of the embodiments below), and with reference to FIGS.26 and 27 .

The tensionable, self-cinching knotless anchor 50 shown in FIGS. 26 and27 has an anchor body 11 provided with a longitudinal axis 11 a, aproximal end 13 and a distal end 12, and a plurality of ribs 15extending circumferentially around it. Openings/channels 16 and 17 allowthreading suture(s) and/or suture passing device(s) around post 20, asdetailed below. Cannulation 11 b extends along the body 11 to allowpassage of flexible strands and of suture passing devices, as detailedbelow. Cylindrical portion 14 is provided at the proximal end 13 of theanchor 50 and contains a socket 19 (FIG. 27 ) configured to securelyengage a tip of a driver. Openings/channels 16, 17 are positionedopposite to each other relative to the post 20 and also symmetricallylocated relative to the post 20, to allow flexible strand 30 (suture 30)and shuttle/pull device 40 (suture passing instrument 40 or shuttle 40)provided with eyelet or loop 44 to pass and slide therethrough.

Tensionable knotless anchor 50 is loaded with tensionable construct 99formed of suture 30 attached to the shuttle/pull device 40. To assembleanchor 50, suture 30, which is typically braided or multi-filament, ispreloaded onto the anchor by tying static knot 31, which prevents suture30 from passing through distal blind hole 12 a. The suture may also bepreloaded by insert molding or by any other means known in the art.Suture 30 passes around post 20, which is large enough to allow suture30 to take gradual turns instead of sharp turns. Suture 30 then passesthrough cannulation 11 b and proximal blind hole 13 a. Tensionableknotless anchor 50 is loaded onto a driver (not shown in FIGS. 26 and 27), and suture 30 is tied to the driver (for example, wrapped around acleft of the driver) to fasten tensionable knotless anchor 50 securelyto the driver.

Prior to the fastening of the anchor 50 to the driver, suture passingdevice 40 (for example, a FiberLink™ or a nitinol loop) is threadedthrough suture 30 (i.e., attached to the suture 30 through splice region39), as shown in FIG. 27 . Suture passing device 40 includes aneyelet/loop 44 for passing suture and, optionally, a pull-ring (notshown). Suture passing device 40 passes through an aperture of suture30, located either proximal or distal to distal blind hole 12 a. It thenexits an aperture of suture 30, within the tensionable knotless anchor50, traverses around post 20, and through proximal blind hole 13 a.Tensionable knotless anchor 50 loaded with tensionable construct 99(formed of suture 30 attached to the suture passing device 40) is thensecured into bone (for example, into a hole/socket/tunnel formed in thebone) by using the driver. Suture 30 is then passed through or aroundthe tissue which is to be reattached to bone. Suture 30 is subsequentlypassed through eyelet/loop 44 of the suture passing device 40. Suturepassing device 40 is then pulled, thereby pulling suture 30 towardstensionable knotless anchor 50 so that it doubles on itself inside thebody of the tensionable knotless anchor. The suture passing device 40has also been further pulled through the splice region 38 of suture 30,to form a splice within the strand 30 and within the body of the anchor50, and a continuous, flexible loop 55 (not shown) having an adjustableperimeter.

Anchor 50 may be a screw-in anchor or a push-in style anchor. Anchor 50may be formed of metal, biocompatible plastic such as PEEK or abioabsorbable material. Socket 19 at the distal end 13 of the anchor 50is configured to securely engage a tip of a driver, as detailed below.The socket of the anchor 50 may have any shape adapted to receive adriver tip for tapping or screw-in style anchors. Tensionable knotlessanchor 50 may be made of one or more pieces, or may be provided as anintegrated device. As detailed below, the tensionable knotless anchor 50may be modified to carry more than one suture/shuttle construct (i.e.,more than a flexible strand 30 and a shuttle/pull device 40), or may bemodified to carry no suture but only one or more shuttle/pull devices,etc. Furthermore, anchors with eyelets may carry one or more sutures orsuture tapes inserted through the eyelet as desired by the surgeon.

Reference is now made to FIGS. 1-25 which illustrate various fixationdevices (suture anchor constructs) and remplisssage techniques andmethods of attaching soft tissue to other tissue (such as bone) withsuch devices/constructs. For simplicity, the remplissage techniques havebeen grouped into four categories (techniques 1-4, or Embodiments A-D)set forth below.

FIGS. 1 a, 1 b , and 2

FIGS. 1 a, 1 b , and 2 illustrate an exemplary surgical devicecomprising fixation device 50 a in the form of a combinedknotless/knotted Corkscrew® with a recessed eyelet 55, tensionableconstruct 99, and optionally sliding suture 30 a. Fixation device 50 acould be used for remplissage and for transtendon PASTA repairs.Flexible strand 30 and shuttling/pulling device 40 (suture passinginstrument 40) that form knotless tensionable construct 99, as well asthe formation of the splice and flexible, tensionable, self-cinchingloop, are similar to those described above with respect to knotlessanchor construct 50 of FIGS. 26 and 27 .

Sliding suture 30 a could be useful for surgeons that want to tie knots,or as a backup fixation if the knotless mechanism fails to functionproperly (e.g., if the suture 30 breaks or gets hung up when threadingthe splice, which sometimes happens during surgery) so that the anchorcould still be used by tying a knot and would not have to be abandoned.One or more sliding sutures 30 a could be provided. Exemplary combinedknotless/knotted Corkscrew® 50 a has a standard corkscrew fully-threadedprofile with recessed PEEK eyelet 55 (eyelet and sutures are ghosted-in)and continuous threads 15 a. PEEK eyelet 55 is housed within bore 29provided at the most distal end 12 and in communication with cannulation11 b and with most distal surface 12 a. Eyelet 55 may include eyeletbody 56 with a throughhole or opening 57, which allows one or moreflexible strands 30 a (sliding sutures 30 a) to slidingly passtherethrough. Eyelet 55 may also include eyelet channel/passage 58through which flexible strand 30 of knotless tensionable construct 99passes through. Eyelet channel 58 may be configured to extend to a holeon a surface of body 56 of the recessed eyelet where a static knot maybe tied to secure tensionable construct 99. Alternatively, eyeletchannel 58 may extend into opening 57 of eyelet 55, where a static knotis tied. In an exemplary embodiment illustrated in FIGS. 1 a -2,flexible strand 30 of knotless tensionable construct 99 passing througheyelet channel/passage 58 is secured on the surface of eyelet 55 bytying a static knot 31.

The PEEK eyelet 55 recessed in tip of anchor body 11 (at most distal end12 of anchor body 11) serves as anchor point for knotless rig, and alsocan accommodate a separate sliding suture 30 a for knotted use (slidingsuture 30 a through eyelet 55 can be used to tie knot, if necessary, dueto either: 1) surgeon's preference; or 2) back-up fixation in the eventthat the knotless mechanism fails to function properly).

Construct 50 a may be inserted with a driver, such as a Corkscrew®driver, and could be inserted trans-tendon through an arthroscopiccannula, for example, a 5 mm cannula.

FIGS. 3 and 4

FIGS. 3 and 4 illustrate an exemplary surgical device using fixationdevice 50 b in the form of a knotless Corkscrew® anchor. Fixation device50 b may be employed with a standard Corkscrew driver, and may beinserted through a 5 mm cannula that could be used for PASTA repairs(i.e., a 4.5 mm version of anchors 50 b could pass through a 5 mmcannula). These fixation devices may be employed for knotlessremplissage techniques with screw-in anchor options.

FIG. 3 illustrates knotless Corkscrew® 50 b which may be formed ofbiocompatible, PEEK or metal material, and is provided with pre-threadedtensionable loop 66 formed within strand 30 that terminates in knot 31at distal end 12. There is no internal post in this embodiment. Thisconstruct could be used with a standard Corkscrew® driver and could beinserted trans-tendon.

FIG. 4 illustrates knotless Corkscrew® 50 c which may be formed ofbiocompatible, PEEK or metal material, and is provided with an internalpost 20 and same threading mechanism as knotless SutureTak® 50 (FIGS. 26and 27 ). This construct could be used with a standard Corkscrew® driverand, therefore, could be inserted trans-tendon through a 5 mm cannula(i.e., a 4.5 mm anchor 50 c that would pass through a 5 mm cannula).Knotless Corkscrew® 50 c could be made in 4.5 mm and 5.5 mm diameters,as well as 3 or 3.5 mm diameters.

As detailed below, knotless Corkscrew® 50 c may be employed specificallyfor remplissage, wherein the surgeon is not just repairing the tissueback to bone but also is filling the bone defect with tendon so that thedefect becomes extra-articular and prevents engagement and dislocationby means of a knotless interlocking suture anchor technique. With theseconstructs, remplissage techniques (particularly remplissage foroff-track lesions) and PASTA repairs become much easier and reproduciblethan the remplissage and PASTA techniques currently known.

FIGS. 5-8

FIGS. 5-8 illustrate two embodiments a surgical device using fixationdevices 50 d, 50 e in the form of knotless SwiveLock® anchors withrecessed eyelet 55, 155 housed within bore 129.

A knotless SwiveLock® with a recessed eyelet shortens the length of theanchor by about 3 mm compared to the regular SwiveLock® (without arecessed eyelet). Construct 50 d, 50 e may be useful with acuteinsertion angles in PASTA repairs and remplissage. In fact, by taking acouple of threads off the anchor body 111, the anchor 111 becomes evenshorter, as necessary in numerous surgical applications.

Preferably, the threaded sleeve 111 of the SwiveLock® inserter isnarrower so that it could fit through a 5 mm cannula, which renders theSwiveLock® construct 50 d, 50 e even more versatile. A thick sleevewould be very difficult to use with the SwiveLock® for transtendonrepairs.

Knotless SwiveLock® 50 d with a Recessed Eyelet 55—First Embodiment

Knotless splice mechanism is external to eyelet 55. The threaded sleeve111 is narrower so that it fits through a 5 mm cannula.

Knotless SwiveLock® 50 e with a Recessed Eyelet 155—Second Embodiment

Knotless splice mechanism is internalized within the eyelet 155 (i.e.,same mechanism as knotless SutureTak®).

The recessed eyelet 55, 155 may be useful in remplissage or PASTA repairby shortening the anchor length by 3 to 4 mm (compared to standardSwiveLock® where eyelet is external). With acute insertion angles, ashorter anchor is desirable.

FIGS. 9 and 10

FIGS. 9 and 10 illustrate two embodiments of a surgical device usingfixation devices 50 f, 50 g in the form of knotless PushLock® anchorswith eyelet 255, 355. Eyelet 255, 355 may or may not be recessed, or maybe partially recessed.

Unlike other PushLock® anchors, fixation devices 50 f and 50 g have acentral cannulation for all accompanying flexible strands and sutures topass through a fixation device body. For example, as shown in FIG. 10 ,flexible strand 30, shuttling/pulling device 40, and sliding suture 30 acan all pass through central cannulation 311 b of body 311. Additionalflexible strands and sliding sutures can be used as desired by thesurgeon. Since eyelet 255, 355 is secured by sutures, it does notrequire threaded attachment to a driver. Eyelet 255, 355 can alsoinclude a cannulation 258, 358.

Fixation devices 50 f, 50 g are advanced by impacting cylinder 360,rather than by being screwed in. Impacting cylinder 360 is cannulated toallow flexible strand 30, shuttling/pulling device 40, and slidingsuture 30 a to pass through the cannulation and exit out of handle 365.

Knotless PushLock® 50 f with Eyelet 255—First Embodiment

Eyelet 255 is configured to have ridges, similar to eyelet 155 offixation device 50 e.

Knotless PushLock® 50 g with Eyelet 355—Second Embodiment

Eyelet 355 is configured to be smooth, similar to eyelet 55 of fixationdevice 50 d.

The above-described fixation devices 50 a-50 g can be used inremplissage techniques. In some ways, these constructs may be superiorto the knotless SutureTak® for remplissage since their pull-out strengthis greater, although the knotless SutureTak® may also be used forknotless remplissage techniques.

FIGS. 11-25 illustrate various exemplary embodiments of remplissagetechniques and PASTA repairs as used with one or more exemplary fixationdevices 50, 50 a-50 g, for example, fixation device 50 d in the form ofa knotless SwiveLock® with a recessed eyelet. With remplissage, thesurgeon is not just repairing the tissue back to bone but the surgeon isalso filling the bone defect with tendon so that the defect becomesextra-articular and prevents engagement and dislocation by means of aknotless interlocking suture anchor technique.

While the remplissage technique has been used for treating off-tracklesions, the new techniques detailed below provide a novel, blind suturepassage through a single cannula with knotless anchors. Biomechanicalstudies have demonstrated that there is a significant stabilizing effectof bringing the tendon into the bone defect and fixing it there.

Remplissage Technology: Embodiments A-D

The inventor of the present application has developed four distinctmethods A, B, C, D of using the knotless SutureTak® device 50 and/or anyof the fixation devices 50 a-50 g as an exemplary application. Thesemethods are referenced as “remplissage” techniques and are describedbelow. The remplissage procedure was initially described in 2007 by Wolfet al. as an adjunct to the arthroscopic anterior stabilizationprocedure of the shoulder in order to address a large engagingHill-Sach's defect. The remplissage technique has been reported to beeffective in reducing the incidence of recurrent anterior shoulderinstability, when used along with arthroscopic Bankart repair.

The remplissage techniques detailed below may be used with threadedanchors such as fixation devices 50 a-50 g. The remplissage techniquesdetailed below may be also used with other devices, such as knotlessCorkscrew®, PushLock®, and SwiveLock® anchors, among others. Thetechniques also find application in PASTA repairs.

The remplissage techniques detailed below fill the bone defect withtendon so that the defect becomes extra-articular and preventsengagement and dislocation by means of a knotless interlocking sutureanchor. The surgeon employs a blind technique for doing this, withoutever having to look up into the subacromial space.

The four remplissage techniques possess very unique and valuablefeatures. The knotless suture anchors employed in such remplissagetechniques may be used around any joint in the body, with the mainapplication to remplissage of the shoulder.

Advantages:

-   1. Reduced surgical time (cutting surgical time by 75% in most    cases).-   2. Expands knotless SutureTak® anchors for other than arthroscopic    labral repairs.-   3. Lower patient risk (less time under anesthesia).-   4. Interlocking of the knotless mechanisms between two anchors    increases the loads to failure, providing a stronger construct.

Remplissage Technique 1—Embodiment A

Steps: The following narrative describes the application of theremplissage technique #1 for treating a Hill-Sach's defect 90 invicinity of rotator cuff tendon 80.

Arthroscopic remplissage with anchor #1 and anchor #2, each providedwith flexible strand 30 and shuttling/pulling device 40 with loop 44(i.e., any of knotless SutureTak® anchor 50 and fixation devices 50 a-50g detailed above).

1. Two cannulas 72, 74 are first put in place, an intra-articularcannula 72 for placement of anchors (fixation devices) and a subacromial/sub deltoid cannula 74 for passing sutures (flexible strands),as shown in FIG. 11 . The sub acromial/sub deltoid cannula 74 can toggleto allow penetration of various instruments such as a suture passer, andthereby the passage of suture (suture/Nitinol needle #1, andsuture/Nitinol needle #2) into the tendon 80 at two different points orlocations.

Two anchors (Anchor #1, Anchor #2) are then placed at the edge of thedefect 90, through the intra-articular cannula 72, as shown in FIG. 12 .

The sub acromial cannula 74 is then pushed against the tendon 80.

2. Retrieve each set of sutures through the sub acromial cannula 74;each set of sutures are to be retrieved through a separatepoint/location in the rotator cuff 80 while viewing from theintra-articular, as shown in FIG. 13 .

3. Pass suture limb from one anchor through the splice of the otheranchor by threading the suture through the Nitinol loop of the oppositeanchor, then pulling reciprocally on the two free Nitinol limbs to bringthe double loop down over the tendon bridge, as shown in FIG. 14 .

4. The final construct/repair 100 is illustrated in FIG. 15 . Asillustrated, the double suture bridge serves to actively compress thetendon 80 into the Hill Sach's defect 90.

Note: The technique may also be adapted for use in the repair of a PASTAlesion with a double loop. Sutures may also be brought laterally to athird anchor where greater footprint compression is desired/clinicallyadvisable. Additional anchors and/or fixation devices may be employed,if necessary and as required by each specific repair.

General Set-Up:

1. One posterior cannula (intra-articular) 72

2. One posterior-lateral cannula (subacromial) 74

Remplissage Technique 2—Embodiment B

Arthroscopic remplissage; this is a blind technique.

The technique unites the two anchor loops with an externally tied loop.The tensionable loops are pre-passed, meaning that the surgeon does nothave to thread the splice in the two anchors, saving time as well aseliminating the possibility of malfunction with the splice passage.

Remplissage technique #2 may be used with various devices, including theknotless SutureTak®, knotless Corkscrew®, Pushlock® and/or SwiveLock®anchors.

Steps: The following narrative describes the application of theremplissage technique #2 for repairing a Hill-Sach's defect 90.

1. Place two pre-looped knotless SutureTak® anchors or knotlessCorkscrew® anchors (anchor #1, anchor #2) through a posterior portal andcannula 72. Intra-articular cannula 74 is illustrated penetrating therotator cuff 80.

2. A separate sub acromial cannula 74 is also illustrated in FIG. 16 ,through which a suture passer 73 is inserted, and used to retrieve eachloop through a separate trans-tendon puncture, as shown in FIG. 17 .

3. Tie a separate loop of suture or suture-tape 69 (FIG. 18 ) betweenthe two tensionable loops (tied outside the cannula 74). Note: It isrecommended that the loop be tied over a 2 cm-circumference post. Thiswill flatten to 1 cm over the cuff. The interposed loop is essential sothat the tensioning limbs will not cause binding as the tensionableloops are pulled down. Consider using a 2 cm length of tape 75 (FIG. 18) with #2 suture leaders for tying, to provide broader compression.

4. Pull on the tensioning limbs to pull loop construct down on rotatorcuff 80 to obtain a final repair (not shown).

Remplissage Technique 3—Embodiment C

The technique allows for creation of two separate knotless mattressstitches by a “blind” technique, in which the looped portion of thethreading suture (the FiberLink® threader or suture passer 40 with loop44) is separately passed so that a bridge of tendon is captured by thecoreless loop as it enters back through the splice in the anchor. Thisremplissage technique may be used with the knotless SutureTak® (knotlessCorkscrew®, PushLock® or SwiveLock®), or any of fixation devices 50 a-50g.

The technique provides the creation of two separately-applied knotlessmattress stitches 85 a, 85 b. FIGS. 19-21 schematically illustrate thisthird technique.

Steps: The following narrative describes the application of theremplissage technique #3.

1. Preplace two knotless SutureTak® or knotless Corkscrew® anchors, withFiberLoop® to thread the splice (FIG. 19 ). Two anchors (Anchor #1,Anchor #2) are then placed at the edge of the defect 90, throughcannulas 74 a, 74 b as shown in FIG. 19 .

2. Pass the sutures for the knotless mattress stitch, with each anchorproviding a separate mattress stitch 85 a, 85 b through a separatecannula 74 a, 74 b (FIG. 20 ).

3. Coreless suture is passed over the tendon 80 via a separate puncturefrom Fiberlink®, providing a 1 cm tissue bridge between the puncturepoints for the mattress stitch 85 a, 85 b (FIG. 20 —note the tensioninglimb of the Fiberlink®; note the threading of the coreless suturethrough the looped end of the Fiberlink®).

4. Pull in direction A (FIG. 21 ) to tension the limbs of the Fiberlink®constructs to pull the tendon 80 to the bone defect 90 with two knotlessmattress sutures or tape/suture composites (mattress stitches 85 a, 85b).

Remplissage Technique 4—Embodiment D

The technique allows for single-portal remplissage.

1. Subacromial cannula 74 is first put in place. Spear guide 76 passesthrough subacromial cannula 74, then penetrates tendon through the pointthat the surgeon wants to be opposed to bone, eliminating steps ofpassing suture through tendon after placing anchor in bone through aseparate cannula. This is done for two separate anchors as shown in FIG.22 .

2. Remove inserter and guide (FIG. 23 ).

3. Thread suture from anchor #1 through nitinol loop from anchor #2.Thread suture from anchor #2 through nitinol loop from anchor #1. Thenpull on tensioning limbs of nitinol wires to close the suture loopstightly down on the tendon, as shown in FIG. 24 .

4. The final construct/repair 200 is illustrated in FIG. 25 . Sutureshave been tightened down into mattress configuration, insetting thetendon into the Hill-Sach's defect 90.

The present disclosure provides methods of stabilizing a bone or jointlesion, by inter alia (i) installing, through a first cannula, aplurality of fixation devices in a bone defect, each of the fixationdevices including a flexible construct extending through the fixationdevice, the flexible construct comprising a flexible strand and acorresponding shuttling/pulling device attached to the flexible strand;(ii) passing, through a second cannula, each of the flexible strandsthrough soft tissue to be fixated, at different locations within thesoft tissue; (iii) passing each of the flexible strands through aneyelet of the shuttling/pulling devices; and (iv) pulling on each of theshuttling/pulling devices to allow each of the flexible strands to forma splice through itself and within the fixation device, and providetensioning of the soft tissue to be fixated relative to the bone defect.

The bone defect may be a Hill-Sach's lesion. The bone defect may be ahumeral head lesion, a femoral head lesion, a tibial head lesion, adistal tibial lesion, or a calcaneus lesion. The first cannula may be anintra-articular posterior cannula for placing the plurality of fixationdevices, and the second cannula may be a subacromial, subdeltoidpostero-lateral cannula for passing the flexible strands.

A plurality of knotless closed loops may be formed, each having anadjustable perimeter. The plurality of knotless closed loops may beinterlocked with each other by another loop formed of suture tape.Adjusting the perimeter of the knotless closed loops approximates thesoft tissue to the bone defect. The soft tissue may be tendon, labrum,Achilles tendon, rotator cuff, biceps or capsular tissue. All steps maybe conducted arthroscopically and without visualizing the subacromialspace.

At least one of plurality of fixation devices can be an anchor with afully-threaded body with a corkscrew profile, a cannulation, a proximalend, a distal end, and a recessed eyelet at the distal end, wherein thecannulation and the recessed eyelet are configured to allow the flexiblestrand and attached shuttling/pulling device to be passed through thebody of the fixation device and through the recessed eyelet. Therecessed eyelet is housed within a bore located at the distal end, thebore being in communication with the cannulation and with a most distalsurface of the fully-threaded body. The shuttling/pulling device isconfigured to be pulled out of the body of the fixation device to allowthe flexible strand to pass through itself and form a splice and acontinuous, knotless, adjustable loop having an adjustable perimeter.

At least one of a plurality of fixation devices can alternatively be ananchor with a ridged body a cannulation, and an eyelet, and is impactedinto place. The cannulation and the eyelet are configured to allow theflexible strand and attached shuttling/pulling device to be passedthrough the body of the fixation device and through the eyelet.

The present disclosure also provides a remplissage technique for aHill-Sach's lesion by inter alia: (i) inserting a posterior,intra-articular cannula through skin and through a rotator cuff tendonlocated over a Hill-Sach's lesion; (ii) inserting at least oneposterolateral subacromial cannula through skin and over the rotatorcuff tendon; installing a plurality of fixation devices into theHill-Sach's lesion, through the posterior, intra-articular cannula, eachof the fixation devices including a flexible construct extending throughthe fixation device, the flexible construct including a flexible strand;(iii) passing, through the at least one posterolateral subacromialcannula, each of the flexible strands through the rotator cuff tendon,at different locations within the rotator cuff tendon; and (iv) fixatingthe rotator cuff tendon with the flexible strands within the Hill-Sach'slesion. The fixation devices may further include a correspondingshuttling/pulling device attached to the flexible strand.

The remplissage technique may further include the steps of: (v) passingeach of the flexible strands through an eyelet of the shuttling/pullingdevices; and (vi) pulling on each of the shuttling/pulling devices toallow each of the flexible strands to form a splice through itself andwithin the fixation device, and a continuous, knotless, self-cinchingloop.

The flexible strands may be passed through the rotator cuff tendon to befixated, and then through its corresponding eyelet of theshuttling/pulling device. The flexible strands may be passed through therotator cuff tendon to be fixated, and then through an eyelet of ashuttling/pulling device of an adjacent fixation device. The flexiblestrands may be passed through the rotator cuff tendon to be fixated, andthen through an eyelet of a different fixation device.

The remplissage technique may further include the steps of: installing afirst and a second fixation devices into the Hill-Sach's lesion, each ofthe first and second fixation devices including a flexible constructextending through each of the first and second fixation devices, theflexible construct comprising a flexible strand and a correspondingshuttling/pulling device attached to the flexible strand; passing eachof the flexible strands through the rotator cuff tendon adjacent theHill-Sach's lesion; passing the flexible strand of the first fixationdevice through an eyelet of the shuttling/pulling device of the secondfixation device, and passing the flexible strand of the second fixationdevice through an eyelet of the shuttling/pulling device of the firstfixation device; and pulling on each of the shuttling/pulling devices toallow each of the flexible strands to form a splice through itself andwithin the fixation device, and provide tensioning of the rotator cufftendon to be fixated within the Hill-Sach's lesion. At least one of thefirst and second fixation devices may be knotless anchor having afully-threaded corkscrew configuration with a recessed eyelet providedat its most distal end.

The present disclosure also provides a remplissage technique for aHill-Sach's lesion by inter alia: (i) inserting a subacromial cannulathrough skin and through a rotator cuff tendon located over aHill-Sach's lesion; (ii) passing a spear guide through the subacromialcannula and penetrating the rotator cuff at a point opposed to bone;(iii) installing a plurality of fixation devices into the Hill-Sach'slesion, through the subacromial cannula, each of the fixation devicesincluding a flexible construct extending through the fixation device,the flexible construct including a flexible strand; and (iv) fixatingthe rotator cuff tendon with the flexible strands within the Hill-Sach'slesion. Each fixation device may further include a correspondingshuttling/pulling device attached to the flexible strand.

The remplissage technique may further include the steps of: (v) passingthe flexible strand of the first fixation device through an eyelet ofthe shuttling/pulling device of the second fixation device, and passingthe flexible strand of the second fixation device through an eyelet ofthe shuttling/pulling device of the first fixation device; and (vi)pulling on each of the shuttling/pulling devices to allow each of theflexible strands to form a splice through itself and within the fixationdevice, and provide tensioning of the rotator cuff tendon to be fixatedwithin the Hill-Sach's lesion.

The knotless suture constructs and systems of the present invention areused in conjunction with any knotless fixation devices which can allow aflexible strand and attached suture passing device to form a splicewithin the body of the fixation device. The fixation devices may be anyof swivel and/or screw-in suture anchors and/or push-in suture anchors(such as an Arthrex SwiveLock® anchor, disclosed in U.S. Pat. No.9,005,246, or a PushLock® anchor, as disclosed in U.S. Pat. No.7,329,272, the disclosures of which are incorporated by reference intheir entirety herewith). The fixation devices may be also any anchors,implants or screws (such as interference screws or tenodesis screws) orany fixation element that allows attachment/fixation of the knotlesssuture construct to bone during the remplissage techniques describedabove. The fixation devices/implants may have various sizes (variousdiameters and/or lengths) and may be formed of biocompatible materialssuch as PEEK, biocomposite materials, metals and/or metal alloys, orcombination of such materials, among others.

The flexible strand 30 may be a high-strength suture, such as anultrahigh molecular weight polyethylene (UHMWPE) suture which is thepreferred material as this material allows easy splicing. Alternatively,the high strength suture may be a FiberWire® suture, which is disclosedand claimed in U.S. Pat. No. 6,716,234, the entire disclosure of whichis incorporated herein by reference. FiberWire® suture is formed of anadvanced, high-strength fiber material, namely ultrahigh molecularweight polyethylene (UHMWPE), sold under the tradenames Spectra(Honeywell) and Dyneema (DSM), braided with at least one other fiber,natural or synthetic, to form lengths of suture material. The preferredFiberWire® suture includes a core within a hollow braided construct, thecore being a twisted yarn of UHMWPE. Typically the suture will be UHWMPEsuture without a core to permit ease of splicing. The shuttle/pulldevice may be a shuttle/pull suture device such as a FiberLink® or aNitinol loop.

The strands may also be formed of a stiff material, or combination ofstiff and flexible materials, depending on the intended application. Thestrands may be also formed of suture tape or a combination of suture andtape, a stiff material, or combination of stiff and flexible materials,depending on the intended application. The strands may also have across-sectional shape that transitions from round (in the case of asuture) to flat (in the case of a suture-tape). The strands may be alsocoated and/or provided in different colors. The knotless anchors of thepresent invention can be used with any type of flexible material orsuture that forms a splice and a loop.

The knotless suture constructs also include sutures that are spliced—atleast in part—in a manner similar to an Arthrex ACL TightRope®, such asdisclosed in U.S. Pat. Nos. 8,439,976 and 8,460,379, the disclosures ofwhich are incorporated by reference in their entirety herein.

1. (canceled)
 2. A device for tissue repairs, comprising: an anchor bodythat is cannulated and that comprises an outer surface having a fixationstructure for securing the anchor body in a bone hole; a tip that isseparable from the anchor body, wherein the tip defines a recessconfigured to hold a flexible material and comprises a proximal firstportion that is insertable into an opening at a distal end of the anchorbody, wherein at least part of the first portion of the tip iscylindrical to facilitate rotation of the tip relative to the anchorbody when the first portion is inserted; and a tensionable constructextending from the first portion of the tip into the anchor body, thetensionable construct comprising a flexible strand defining twoapertures at different locations along a length of the flexible strand,and a passage extending through the flexible strand and connecting thetwo apertures, for forming a splice and a loop with an adjustableperimeter adjacent the splice.
 3. The device of claim 2, wherein thecylindrical part of the first portion of the tip defines a greatestwidth of the first portion of the tip to facilitate the rotation of thetip relative to the anchor body when the first portion is inserted. 4.The device of claim 2, wherein the tip further comprises a tip body thatis distal to the first portion of the tip and that defines the recess,and wherein a width of the tip body is greater than a greatest width ofthe first portion of the tip.
 5. The device of claim 4, wherein thefirst portion of the tip is cannulated and defines a passage thatextends into the tip body.
 6. The device of claim 4, wherein the recessforms an eyelet that extends transversely through the tip body.
 7. Thedevice of claim 2, wherein the flexible strand of the tensionableconstruct further comprises the splice formed at the passage and theloop, and wherein the loop is a knotless, tensionable, self-cinchingloop with the adjustable perimeter.
 8. The device of claim 2, whereinthe tensionable construct further comprises a knot and a free end. 9.The device of claim 2, wherein the passage forms a coreless portion ofthe flexible strand.
 10. The device of claim 2, further comprising theflexible material that is separate from the tensionable construct,wherein the flexible material is releasably held in the recess.
 11. Thedevice of claim 2, wherein the tip is insertable into the anchor bodysuch that the entire recess of the tip is located inside the anchorbody.
 12. The device of claim 2, wherein the tip further comprises asolid portion formed along a longitudinal axis of the tip that separatesthe recess from a proximal end of the tip.
 13. The device of claim 2,wherein the tensionable construct is separated entirely from the recess.14. A device for tissue repairs, comprising: an anchor body that iscannulated and that comprises an outer surface having a fixationstructure for securing the anchor body in a bone hole; a tip that isseparable from the anchor body, wherein the tip defines a recessconfigured to hold a flexible material and comprises a proximal firstportion that is insertable into an opening at a distal end of the anchorbody; and a tensionable construct extending from the first portion ofthe tip into the anchor body, the tensionable construct comprising aflexible strand defining two apertures at different locations along alength of the flexible strand, and a passage extending through theflexible strand and connecting the two apertures, for forming a spliceand a loop with an adjustable perimeter adjacent the splice; wherein thetensionable construct is fixedly connected to the tip, with a firstsegment of the tensionable construct extending distally along a firstdirection from the first portion of the tip towards a distal end of thetip and a second segment of the tensionable construct extending awayfrom a distal end of the first segment along a second directiondifferent from the first direction.
 15. The device of claim 14, whereinthe first and second segments of the tensionable construct are directlyconnected to one another with the second segment angled around part ofthe tip relative to the first portion.
 16. The device of claim 14,wherein the second segment of the tensionable construct extendslaterally through the tip to an opening on an outer side surface of thetip.
 17. The device of claim 14, wherein the tip further comprises asolid portion formed along a longitudinal axis of the tip that separatesthe recess from a proximal end of the tip.
 18. The device of claim 14,wherein the tip further comprises a tip body that is distal to the firstportion of the tip and that defines the recess, and wherein a width ofthe tip body is greater than a greatest width of the first portion ofthe tip.
 19. The device of claim 18, wherein the first portion of thetip is cannulated and defines a passage that extends into the tip body.20. The device of claim 14, wherein the tensionable construct furthercomprises a knot and a free end.
 21. The device of claim 14, wherein thepassage forms a coreless portion of the flexible strand.
 22. A devicefor tissue repairs, comprising: an anchor body that is cannulated andthat comprises an outer surface having a fixation structure for securingthe anchor body in a bone hole; a tip that is separable from the anchorbody, wherein the tip defines a recess configured to hold a flexiblematerial and comprises a proximal first portion that is insertable intoan opening at a distal end of the anchor body; and a tensionableconstruct extending from the first portion of the tip into the anchorbody, the tensionable construct comprising a flexible strand definingtwo apertures at different locations along a length of the flexiblestrand, and a passage extending through the flexible strand andconnecting the two apertures, for forming a splice and a loop with anadjustable perimeter adjacent the splice; wherein the tensionableconstruct is fixedly connected to the tip without extending through anydistally facing opening on the tip.
 23. The device of claim 22, whereinpart of the tensionable construct extends laterally through the tip toan opening on an outer side surface of the tip.
 24. The device of claim22, wherein the tip further comprises a tip body that is distal to thefirst portion of the tip and that defines the recess, and wherein awidth of the tip body is greater than a greatest width of the firstportion of the tip.
 25. The device of claim 22, wherein the tensionableconstruct further comprises a knot and a free end.
 26. The device ofclaim 22, wherein the passage forms a coreless portion of the flexiblestrand.